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Ultra-short Glucocorticosteroids and Tocilizumab Therapy in GCA Patients

NCT05394909 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-06-12

No results posted yet for this study

Summary

The objective of our study is to evaluate the functional and morphological imaging variations at 24 and 52 weeks compared to baseline during TCZ-treatment and 6 months after the suspension of TCZ. We will also evaluate the variations of aortic dilatation during the study period using the PET/CT in comparison with an hystorical cohort of patients with LVV treated with GCs only and longitudinally followed at our rheumatology division.

Conditions

  • GCA
  • TOCILIZUMAB
  • Glucocorticoids
  • PET

Interventions

DRUG

Tocilizumab 162Mg/0.9Ml Autoinjector

Patients will receive high-dose pulse intravenous methylprednisolone (500 mg ) for 3 consecutive days (Day 0-1-2) and subsequently will be treated weekly with Tocilizumab 162 mg s.c. for 52-weeks and then following according to SOC

Sponsors & Collaborators

  • Azienda USL Reggio Emilia - IRCCS

    lead OTHER_GOV

Principal Investigators

  • carlo salvarani, MD · AUSL-IRCCS REGGIO EMILIA

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-07
Primary Completion
2022-02-25
Completion
2022-10-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05394909 on ClinicalTrials.gov